A new clinical study evaluating Perosphere Technologies Inc.'s ClotChek rapid, point-of-care coagulometer was published in the international journal Thrombosis and Haemostasis, the Danbury-based medical technology company announced.

The study evaluated ClotChek Clotting Time (CKCT) in patients receiving Factor Xa (FXa) inhibitors apixaban and rivaroxaban, demonstrating direct oral anticoagulant (DOAC) sensitivity and strong correlations between CKCT and DOAC-related anti-FXa drug levels when patients were categorized based on Medical Decision Limits (MDL). The study also showed the device's ability to detect clinically meaningful anticoagulation at both greater than 75 ng/mL and greater than 30 ng/mL MDL thresholds.

Sasha Bakhru, PhD, co-author and CEO of Perosphere, said, "These findings support the potential for ClotChek to address a longstanding unmet clinical need for rapid, bedside assessment of DOAC anticoagulant effect. Results can help inform decision making in time-sensitive patient scenarios such as major bleeding, acute ischemic stroke, trauma, and emergent surgery."

ClotChek provides a pharmacodynamic measurement of a patient's coagulation status in whole blood without reagents, demonstrating sensitivity at lower drug concentrations, where understanding a patient's degree of anticoagulation can be particularly important for critical decisions.

"Without rapid, objective assessment of anticoagulation status for DOAC patients, clinicians may be forced to make empiric treatment decisions - or even delay or defer potentially time-sensitive interventions," said Dr. Jack Ansell, MD, co-author and former Chairman, Department of Medicine at Lenox Hill Hospital.

Perosphere develops point-of-care diagnostics to support clinical decision-making for patients receiving anticoagulant therapy or at risk of bleeding, with ClotChek designed to rapidly measure whole blood clotting time in three to eight minutes.